Description
Description:*Provide QA support to site start-up activities by maintaining the site Inspection Readiness program.
*Review and participate in deviations and change controls to ensure appropriate investigation and assessment is carried out and actions implemented and monitored.
*Support/maintain operation of the site Training system, including preparing and presenting relevant training material, as required.
*Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.
*Keep abreast of regulatory initiatives and new guidance/requirements
Qualifications:
*Educated to degree level (Life Sciences or Chemistry) with 5+ years industry experience.
*Working knowledge of US FDA, 21 CFR part 210 and 211 and EU GMP requirements
*Previous experience in maintaining Training and / or Vendor Management systems required
*Experience in designing and implementing quality or regulatory compliance systems and/or a start-up desirable
*Experience in or knowledge of inhalation dosage forms an advantage.
*High proficiency in Microsoft Word/Excel/Powerpoint/MS Project etc.
*Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
*Good team working and strong communication skills across functions and organization.
If you are interested in this position please contact Sarah Irvine on or reply with a copy of your up to date CV.
Kind regards,
Sarah Irvine